BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISOFLEX OPTIM LEAD

    MDR report key: 3924094 · Received July 9, 2014

    Report

    Report Number
    2017865-2014-15023
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Date of Event
    April 16, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NVN
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL ANALYSIS FOUND THE LEAD WAS RETURNED IN ITS UNOPENED STERILE TRAYS WITHOUT THE OUTER BOX AND LABELS. IT COULD NOT BE DETERMINED IF THE LEAD WAS SHIPPED WITHOUT THE LABELS. (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PACKAGED LEAD WAS OPENED AND MISSING LEAD STICKERS. THE LEAD WAS NOT USED AND RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399719 ISOFLEX OPTIM LEAD PERMANENT PACEMAKER ELECTRODE NVN ST. JUDE MEDICAL, INC., CRMD 1948/52 NA

    Patients

    Seq Age Sex Outcome Treatment
    1